ERBE VIO ESU WITH ACCESSORIES, MODEL VIO 300 D— 510(k) K023886
Substantially EquivalentErbe USA, Inc.
FDA 510(k) clearance K023886 for ERBE VIO ESU WITH ACCESSORIES, MODEL VIO 300 D, Substantially Equivalent on 2002-12-12. Applicant: Erbe USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Erbe USA, Inc.
- Product code
- Product code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Marietta, GA, US
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More clearances from Erbe USA, Inc.
view allAdverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.